BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PICC-NATE

    MDR report key: 523141 · Received April 28, 2004

    Report

    Report Number
    523141
    Event Type
    Injury
    Date Received
    April 28, 2004
    Date of Event
    April 19, 2004
    Report Date
    April 21, 2004
    Manufacturer
    UTAH MEDICAL PRODUCTS
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CVL PLACED IN 2004. WHEN REMOVED ABOUT TWO WEEKS LATER, IT BROKE. A CUT DOWN WAS PERFORMED TO REMOVE THE REMAINING CATHETER SEGMENT. NO LONGTERM EFFECTS ARE ANTICIPATED.

    Description of Event or Problem · 1

    ADD'L INFO RECEIVED FROM MFR 6/29/04. INFO INDICATED IT WAS NOT AN ADVERSE EVENT, BUT IT WAS A PRODUCT PROBLEM WHICH REQUIRED A CUT DOWN SURGICAL INTERVENTION. RECEIVED A PORTION OF THE SEVERED CATHETER. AN INTERNAL INVESTIGATION FOUND THAT ON 4/04 MEDICAL CENTER REPORTED A PICC CATHETER BROKE AT THE 11CM MARK. CO BELIEVES NOW IT WAS THE SAME EVENT. IT WAS UNCLEAR WHETHER OR NOT THE CATHETER WAS UTMD'S. INFUSING LIFE-SAVING FLUIDS, ESPECIALLY CONCENTRATED OR IRRITATING MEDICINES, DIRECTLY INTO THE VENA CAVA RATHER THAN THROUGH PERIPHERAL INFUSION, HAS BEEN KNOWN IN MEDICAL PRACTICE FOR OVER 50 YEARS TO ACHIEVE BETTER CLINICAL RESULTS FOR A CRITICALLY-ILL PT. THE PICC-NATE AND UMBILI-CATH PRODUCTS ARE INTRAVASCULAR ACCESS CATHETERS DESIGNED FOR THAT PURPOSE IN NEONATES. ACCORDING TO UTMD'S JUNE 2000 PICC 510(K) NO K001874 SUBMISSION, "THE PICC WILL ONLY BE USED BY CLINICIANS WHO ARE VERY FAMILIAR WITH THE USE AND TECHNIQUES INVOLVED WITH PICC PRODUCTS AND WHO ARE SPECIALLY TRAINED IN PLACING PERCUTANEOUS CATHETERS. INSERTION TECHNIQUE MAY VARY SOMEWHAT DEPENDING ON INDIVIDUAL HOSPITAL PROTOCOLS AND CLINICIAN PREFERENCES." BECAUSE PRACTITIONERS IN NICUS ARE SPECIALLY TRAINED IN PLACING THESE CATHETERS, UTMD DOES NOT INDEPENDENTLY PROVIDE TRAINING MATERIALS. UTMD'S ADVISORY PRACTITIONERS EXPLAIN THAT IT IS NOT UNUSUAL TO TAKE 20-30 MINUTES TO PLACE A 1.9 FRENCH SILICONE CATHETER, GRIPPING VERY LIGHTLY WITH MICRO-FORCEPS AND MAKING VERY SMALL ADVANCES. PLEASE HANDLE THE ENCLOSED 1.9 FRENCH CATHETER, WHICH WAS THE SAME PART NUMBER USED IN THE RMC EVENT, TO GAIN AN APPRECIATION FOR THE FRAGILITY OF THE CATHETER. THE 1.9 FRENCH CATHETER IS THE SMALLEST AVAILABLE FROM ANY MFR. THE SMALL SIZE ALLOWS PICC PLACEMENT IN A SMALLER BABY WHICH WOULD OTHERWISE NEED MORE INTENSIVE MEANS FOR INFUSION INTO THE VENA CAVA. IN THE MOST RECENT THREE YEARS SINCE JUNE 29, 2001, UTMD HAS RECEIVED NOTICE OF THREE SEVERED SILICONE INTRAVASCULAR CATHETER WHICH REQUIRED SURGICAL INTERVENTION INCLUDING THIS EVENT, OUT OF 98432 CATHETERS SHIPPED. TWO CATHETER SEGMENTS, ONE 4CM LONG AND ONE 7CM LONG WERE RETURNED. POINT A HAS THE APPEARANCE THAT IT WAS PULLED OFF A PART OF THE CATHETER WHICH WAS NOT RETURNED. RETURNED PIECES WERE SEVERED AT POINT B & C. THE SURFACE AT B & C IS CONSISTENT WITH A CATHETER WHICH WAS DAMAGED PRIOR TO PULLING APART. AT POINT D IT APPEARS THAT A PIECE OF THE CATHETER WAS CUT FROM THE SEGMENT. IN ORDER TO VERIFY ADEQUATE TENSILE STRENGTH AND ELONGATION BOTH RETURNED CATHETER SEGMENTS WERE PULL TESTING USING AN INSTRON TESTER. THE FORCE REQUIRED A PULL SEGMENTS AB APART WAS 0.301 POUNDS & SEGMENT CD WAS 0.393 POUNDS. THE ELONGATION PRIOR TO THE BREAK WAS > 500% ON BOTH PIECES. (SPECIFICATIONS: BREAK FORCE 0.20 POUNDS MIN, ELONGATION (300% MIN). THE STRUCTURAL STRENGTH OF THE CATHETER SEGMENTS EXCEEDED SPECIFICATIONS. CONCLUSION: THE CATHETER BREAK AT POINT BC WAS RELATED TO CATHETER DAMAGE WHICH OCCURRED PRIOR TO AND/OR THE CATHETER REMOVAL. AFTER THE ABOVE ANALYSIS THE FOLLOWING CONCLUSIONS WERE MADE: THE 4CM PIECE, A END WAS PULLED FROM THE CATHETER (TENSILE FORCE BREAK) THE PIECE OF CATHETER, MOST LIKELY THE HUB END WAS NOT RETURNED TO UTMD FOR EVALUATION. THE 4CM PIECE AT POINT B WAS SEPARATED FROM THE 7CM PIECES AT POINT C. IT APPEARS THAT THE CATHETER WAS DAMAGED AT POINT B & C PRIOR TO BEING PULLED APART. THE 7CM SEGMENT WAS CUT FROM THE CATHETER AT POINT D. THIS MAY HAVE BEEN DONE WHEN THE CATHETER WAS CUT TO LENGTH PRIOR TO INSERTION. FROM INFO AVAILABLE IT COULD NOT BE DETERMINED WHICH OF THE SEVERS OCCURRED WHILE REMOVING THE CATHETER, BUT IT IS MOST LIKELY THE SEVER OF THE 4CM SEGMENT AT POINT B FROM THE 7CM PIECE AT POINT C. THE ONLY REPRODUCTION OF A CATHETER SEVER WHICH WAS SIMILAR TO THIS SEVER WAS THE CATHETERS WHICH WERE BURST PRIOR TO PULLING THE CATHETERS APART. WHEN THE RETURNED CATHETER WAS PULL TESTED, THE FORCE REQUIRED TO PULL THE CATHETER APART AND THE ELONGATION PERCENTAGE WERE HIGHER THAN SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PICC-NATE CENTRAL VENOUS CATHETER DQO UTAH MEDICAL PRODUCTS PC-2PS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 19 DAY Required Intervention